Capecitabine, Docetaxel and Gemcitabine in Patients With Advanced Pancreas Cancer

This study has been completed.
Sponsor:
Collaborator:
University of Michigan Cancer Center
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00320749
First received: April 28, 2006
Last updated: September 15, 2015
Last verified: September 2015
Results First Received: September 15, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Interventions: Drug: Capecitabine
Drug: Docetaxel
Drug: Gemcitabine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were enrolled into the study between December 2005 and February 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients had histologically or cytologically confirmed metastatic pancreatic adenocarcinoma and measurable disease per RECIST criteria.

Reporting Groups
  Description
Dose Level 1 Docetaxel IV over 30 min on days 1 and 8 Capecitabine PO in split doses bid on days 8-21 Gemcitabine IV over 75 min on days 8 and 15
Dose Level 2 Docetaxel IV over 30 min on days 1 and 8 Capecitabine PO in split doses bid on days 8-21 Gemcitabine IV over 75 min on days 8 and 15
Dose Level 3 Docetaxel IV over 30 min on days 1 and 8 Capecitabine PO in split doses bid on days 8-21 Gemcitabine IV over 75 min on days 8 and 15

Participant Flow:   Overall Study
    Dose Level 1     Dose Level 2     Dose Level 3  
STARTED     3     8     10  
COMPLETED     3     6     1  
NOT COMPLETED     0     2     9  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
18 evaluable

Reporting Groups
  Description
Capecitabine, Gemcitabine and Docetaxel Docetaxel i.v. over 30 min on days 1 and 8; Capecitabine p.o. in split doses bid on days 8-21, Gemcitabine i.v. over 75 min on days 8 and 15.

Baseline Measures
    Capecitabine, Gemcitabine and Docetaxel  
Number of Participants  
[units: participants]
  21  
Age, Customized  
[units: years]
Mean (Full Range)
 
Mean age     59  
  (48 to 72)  
Gender  
[units: patients]
 
Female     13  
Male     8  
Region of Enrollment  
[units: participants]
 
United States     21  
Eastern Cooperative Oncology Group (ECOG)  
[units: patients]
 
ECOG 0 (Fully Active)     4  
ECOG 1 (Restricted physical activity)     17  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximum Tolerated Dose   [ Time Frame: Weekly ]

2.  Secondary:   Common Toxicities   [ Time Frame: Weekly ]

3.  Secondary:   Therapeutic Response   [ Time Frame: Prior to cycle 3 and then every 2 cycles thereafter ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tanios Bekaii-Saab, M.D.
Organization: The Ohio State University Comprehensive Cancer Center
phone: 614-293-9863
e-mail: Tanios.Bekaii-Saab@osumc.edu


Publications of Results:

Responsible Party: Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00320749     History of Changes
Other Study ID Numbers: OSU-05058
Study First Received: April 28, 2006
Results First Received: September 15, 2015
Last Updated: September 15, 2015
Health Authority: United States: Food and Drug Administration